BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Prosthesis, Finger, Semi-Constrained, Metal/Polymer

    PMA: P240020 · Supplement: S005 · Decision Apr 13, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Prosthesis, Finger, Semi-Constrained, Metal/Polymer
    Trade Name
    TOUCH® CMC 1 Prosthesis
    PMA Number
    P240020
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    SFA
    Generic Name
    Prosthesis, finger, semi-constrained, metal/polymer
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 13, 2026
    Date Received
    March 13, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for the addition of new sealing equipment at two existing manufacturing sites.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SFA Prosthesis, Finger, Semi-Constrained, Metal/Polymer